×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Efficient Preparation of Global CMC Dossiers
Session Chair(s)
John Smart, PhD
Senior Director and Group Manager, Regulatory CMC
United Kingdom
Preparation and maintenance of dossiers for a global market is exceedingly complex, due to different expectations for regulatory agencies across the globe. Efficiently creating a dossier to effectively meet worldwide requirements requires careful planning. This session will provide some practical and pragmatic approaches for managing the complexity of global CMC dossiers.
Learning Objective : Describe the key regulatory considerations for preparation of a global CMC dossier; Discuss some of the global harmonization efforts that are underway.
Speaker(s)
Global CMC Dossiers: Preparation is Key
Angela McGillivary, PhD
PAREXEL, United Kingdom
Principal Consultant
Regulatory CMC Roadmaps for Fast-Evolving Global Markets (Brazil, China, India, Russia and Turkey)
Monika Jain, PhD
PPD, United States
Manager , Regulatory Affairs CMC, Regulatory Development Solutions
Have an account?